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TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack , Adjutor Healthcare Pty Ltd, CON-1349
Product name
TACHOSIL human fibrinogen 5.5mg/square cm and human thrombin 2.0IU/square cm medicated sponge blister pack
Sponsor name
Adjutor Healthcare Pty Ltd
Consent start
Consent no.
CON-1349
Duration
The consent is effective from 16 April 2025 until 30 September 2026.
Standard
Subparagraphs 10(13)(a)(vi), 10(13)(a)(vii) and 10(13)(a)(x) of Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product's immediate blister pack labels do not include the names and
quantities of all active ingredients in the medicine and the name of local
sponsor of the medicine.
Conditions imposed
Import, Supply, &/or Export
import and supply
Therapeutic product type
Blood, tissues, and biologicals